AAMI ISO 11195:1995 pdf download - Gas mixers for medical use – Stand-alone gas mixers 5 Normal operating conditions 5.1 Normal operating conditions shall be with the gas mixer connected to inlet gas supplies at all pressults...
AAMI ISO 10993-16:2017 pdf download – Biological evaluation of medical devices
AAMI ISO 10993-16:2017 pdf download - Biological evaluation of medical devices 4.3 The results of extraction studies (see ISO 10993-12 and ISO 10993-18 ) should be considered in order to determine the methods to be used for...
AAMI ISO 10993-11:2017 pdf download – Biological evaluation of medical devices
AAMI ISO 10993-11:2017 pdf download - Biological evaluation of medical devices 4.1 General Before a decision to perform a systemic toxicity test is made, ISO 10993-1 shall be taken into account. The decision to perform a test...
AAMI ISO 10993-4:2017 pdf download – Biological evaluation of medical devices
AAMI ISO 10993-4:2017 pdf download - Biological evaluation of medical devices 6.1 General requirements IMPORTANT — Since this is a horizontal International Standard, sound rationales can be supplied to justify the choice of test category(ies) based on...
AAMI ISO 10993-3:2003 pdf download – Biological evaluation of medical devices
AAMI ISO 10993-3:2003 pdf download - Biological evaluation of medical devices 4.1 General Before a decision to perform a genotoxicity test is made, ISO 10993-1 and the chemical characterization of materials (ISO 10993-18) shall be taken into...
AAMI ISO 10993-1:2018 pdf download – Biological evaluation of medical devices
AAMI ISO 10993-1:2018 pdf download - Biological evaluation of medical devices 4.4 The biological evaluation shall commence with categorization of medical devices (see Clause 6). Assessment of the information already available then enables a gap analysis to...
AAMI ISO 10651-4:2002 pdf download – Lung ventilators
AAMI ISO 10651-4:2002 pdf download - Lung ventilators 1 Scope This European Standard specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals...
AAMI ISO 10079-3:1999 pdf download – Medical suction equipment
AAMI ISO 10079-3:1999 pdf download - Medical suction equipment 4 Cleaning, disinfection and sterilization 4.1 Any filters installed shall either be of the single-use type or be capable of being cleaned, disinfected and/or sterilized for re-use. 4.2...
AAMI ISO 10079-2:1999 pdf download – Medical suction equipment
AAMI ISO 10079-2:1999 pdf download - Medical suction equipment 1 Scope This part of ISO 1 0079 specifies safety and performance requirements for manually powered medical suction equipment intended for oro-pharyngeal suction. It covers equipment operated by...
AAMI ISO 5366-3:2001 pdf download – Anaesthetic and respiratory equipment – Tracheostomy tubes
AAMI ISO 5366-3:2001 pdf download - Anaesthetic and respiratory equipment - Tracheostomy tubes 1 Scope This part of ISO 5366 gives requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from to...